Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-28 @ 10:54 AM
Study NCT ID:
NCT05536661
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2022-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Tear Substitute Use on Dry Eye in Gamers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard Patient Evaluation of Eye Dryness (SPEED)', 'timeFrame': 'Between Day 1 and Day 3', 'description': 'Change in Standard Patient Evaluation of Eye Dryness (SPEED) score between study and control group (range 0-28, with higher scores indicative of dry eye disease symptoms)'}], 'secondaryOutcomes': [{'measure': 'Conjunctival hyperemia measured with McMonnies Chapman scale', 'timeFrame': 'Between Day 1 and Day 3', 'description': 'Change in McMonnies Chapman score (range 0-5, with higher scores indicative of more conjunctival hyperemia) between study and control group'}, {'measure': 'Tear Breakup Time (TBUT)', 'timeFrame': 'Between Day 1 and Day 3', 'description': 'Change in Tear Breakup Time (TBUT) score (normal values \\> or equal to 10 seconds) between study and control group'}, {'measure': 'Conjunctival staining with lisamine green measured with Oxford scale', 'timeFrame': 'Between Day 1 and Day 3', 'description': 'Change in conjunctival oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group'}, {'measure': 'Corneal staining with fluorescein measured with Oxford scale', 'timeFrame': 'Between Day 1 and Day 3', 'description': 'Change in corneal oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group'}, {'measure': 'Schirmer I tear volume test', 'timeFrame': 'Between Day 1 and Day 3', 'description': 'Change in Schirmer score (normal values equal or higher than 10) between study and control group'}, {'measure': 'Near convergence measured with a RAF binocular gauge', 'timeFrame': 'Between Day 1 and Day 3', 'description': 'Change in near convergence between study and control group'}, {'measure': 'Accomodation distance measured with a RAF binocular gauge', 'timeFrame': 'Between Day 1 and Day 3', 'description': 'Change in accomodation distance between study and control group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaporative Dry Eye']}, 'descriptionModule': {'briefSummary': 'Clinical, prospective, comparative, controlled, single-blind study, on the signs and symptoms of dry eye before and after 3 days of playing video games with the use of artificial tears (Hyabak) versus no intervention.', 'detailedDescription': 'Adult attendees to a Gamers convention will complete questionnairs and undergo an opthalmological evaluation before and after playing for 3 days in a row. Participants will be randomized into 2 groups of equal size:\n\n1. Study group.\n2. Control group. The Study group will instill hyaluronic acid 0.15% artificial tears in both eyes 4 times a day during the 3 days of the video game session, while the control group will not instill artificial tears.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Participants in videogame convention planning to play video games for a minimum of 6 hours daily for the next 3 days.\n* Voluntarily accept to participate and sign informed consent form\n\nExclusion Criteria:\n\n* Ocular, nasolagrimal or palpebral active condition different from dry eye disease.\n* History of ocular trauma or infecction in the last 3 months previous to inclusion.\n* History of refractive surgery.\n* Visual acuity 0.5 or less in at least 1 eye.\n* Ocular medication use in the 3 days prior to inclusion.\n* History of systemic condition asociated to dry eye.\n* Use of systemic medication known to induce dry eye in the last 30 days.\n* Known allergy to hyaluronic acid.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT05536661', 'acronym': 'HYAGAME', 'briefTitle': 'Impact of Tear Substitute Use on Dry Eye in Gamers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Thea, Spain'}, 'officialTitle': 'Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.', 'orgStudyIdInfo': {'id': 'THEA-HYA-GAMERS-2019-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Preservative free Hyaluronic acid 0.15% artificial tear instilled in both eyes 4 times daily for 3 days', 'interventionNames': ['Other: Preservative free hyaluronic acid artificial tear']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No artificial tear instilation'}], 'interventions': [{'name': 'Preservative free hyaluronic acid artificial tear', 'type': 'OTHER', 'description': 'Ocular lubricant', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46035', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Dreamhack Convention', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Thea, Spain', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Crossdata', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}